Leucoprep(R) Brand Cell Separat Tube W/Sodium Citr
FDA 510(k) K911731 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK911731
Submission
- Device name
- Leucoprep(R) Brand Cell Separat Tube W/Sodium Citr
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- April 17, 1991
- Decision date
- December 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCF – Lymphocyte Separation Medium
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8500
- Specialty
- Hematology
Other 510(k)s with product code JCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K902445 | Lympho Sep(Tm)JCF · Traditional | Icn Biomedicals, Inc. | 08/22/1990SE |
| K891407 | Leucoprep Cell Separation TubeJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/26/1989SE |
| K874328 | L-Phenylalanine Methyl Ester Hydrochloride Pme ReaJCF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/16/1988SE |
| K873185 | Dynabeads Hla Cell Prep II Isolation ProductJCF · Traditional | Dynal Biotech, Inc. | 11/04/1987SE |
| K872775 | Leucoprep Brand TubeJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/02/1987SE |
| K860354 | Sepracell Lymphocyte Separation MediumJCF · Traditional | Sepratech Corporation C/O Keller and Heckman | 04/18/1986SE |
| K854093 | Leuco PrepJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/12/1985SE |
| K842818 | CSTJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/23/1984SE |
| K842146 | HISTOPAQUE-1077JCF · Traditional | Sigma Chemical Co. | 07/27/1984SE |
| K812947 | Mono-Poly Resolving MediumJCF · Traditional | Flow Laboratories, Inc. | 03/11/1982SE |
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| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Leucoprep(R) Brand Cell Separat Tube W/Sodium Citr cleared by the FDA?
Leucoprep(R) Brand Cell Separat Tube W/Sodium Citr (K911731) received a 510(k) decision of Substantially Equivalent on December 15, 1992, 608 days after the submission was received.
What is the product code of K911731?
The FDA product code is JCF – Lymphocyte Separation Medium, a Class I (low risk) device regulated under 21 CFR 864.8500.